{"data":[{"id":"9bc593c5-dd56-4b41-9d9e-5c31e4a05cdc","company_name":"ロシュ・ダイアグノスティックス株式会社","company_name_en":null,"corporate_number":null,"authority":"厚生労働省","authorities":["厚生労働省"],"authority_count":1,"action_types":["承認"],"regional_record_count":1,"source_document_count":1,"law_name":"医薬品医療機器等法","action_type":"承認","action_date":"2022-08-24","announcement_date":"2026-05-05","violation_summary":"医薬品医療機器等法に基づく一般用新型コロナウイルス抗原定性検査キットの承認について","violation_summary_en":"The Ministry of Health, Labour and Welfare approved an over-the-counter COVID-19 antigen qualitative test kit developed by Roche Diagnostics Corporation on August 24, 2022, under the Pharmaceuticals and Medical Devices Act, Article 23-2-5, Paragraph 1.","penalty_amount":null,"is_verified":false,"record_verified":false,"entity_match":{"status":"unresolved","confidence":85,"method":"nta_strict_name_nationally_unique","notes":"A current-policy Corporate Number match to a verified company profile is not available."},"human_review_status":"unreviewed","source_url":"https://www.mhlw.go.jp/stf/newpage_27545.html","url":"https://regbase.jp/enforcement/other-rosiyudaiagunosuteitukusu-20220824"},{"id":"adce976a-17a8-49aa-b272-4397eaa7361f","company_name":"ロシュ・ダイアグノスティクス株式会社","company_name_en":null,"corporate_number":null,"authority":"厚生労働省","authorities":["厚生労働省"],"authority_count":1,"action_types":["承認"],"regional_record_count":1,"source_document_count":1,"law_name":"薬機法","action_type":"承認","action_date":"2022-08-17","announcement_date":"2026-04-21","violation_summary":"新型コロナウイルス抗原検査キットのOTC化を迅速に承認していただきました。誠にありがとうございました。","violation_summary_en":"The OTC approval for the COVID-19 antigen test kit was granted promptly. Thank you very much.","penalty_amount":null,"is_verified":false,"record_verified":false,"entity_match":{"status":"unresolved","confidence":60,"method":"extracted_japanese_name","notes":"A current-policy Corporate Number match to a verified company profile is not available."},"human_review_status":"unreviewed","source_url":"https://www.mhlw.go.jp/stf/newpage_28612.html","url":"https://regbase.jp/enforcement/yakkiho-rosiyudaiagunosuteikusu-20220817"},{"id":"21e852a8-a139-4eb0-b09e-a1bb7d85715f","company_name":"ロシュ","company_name_en":null,"corporate_number":null,"authority":"厚生労働省","authorities":["厚生労働省"],"authority_count":1,"action_types":["許可取消し"],"regional_record_count":1,"source_document_count":1,"law_name":"薬機法","action_type":"許可取消し","action_date":"2022-08-17","announcement_date":"2026-04-28","violation_summary":"インターネット等で入手可能な抗原検査キットのOTC化を認めた。","violation_summary_en":"Approved OTC status for antigen test kits available on the internet.","penalty_amount":null,"is_verified":false,"record_verified":false,"entity_match":{"status":"unresolved","confidence":60,"method":"extracted_japanese_name","notes":"A current-policy Corporate Number match to a verified company profile is not available."},"human_review_status":"unreviewed","source_url":"https://www.mhlw.go.jp/stf/newpage_28612.html","url":"https://regbase.jp/enforcement/yakkiho-rosiyu-20220817"},{"id":"bdb870a2-dc6a-43ea-b217-de332a32d03a","company_name":"ロシュ・ダイアグノスティックス株式会社","company_name_en":null,"corporate_number":null,"authority":"厚生労働省","authorities":["厚生労働省"],"authority_count":1,"action_types":["承認"],"regional_record_count":1,"source_document_count":1,"law_name":"薬機法","action_type":"承認","action_date":"2022-08-17","announcement_date":"2026-05-05","violation_summary":"新型コロナウイルス抗原検査キットのOTC化を迅速に承認していただきました。","violation_summary_en":"The Ministry of Health, Labour and Welfare approved the OTC status of a COVID-19 antigen test kit from Roche Diagnostics Corporation on August 17, 2022, facilitating rapid online sales.","penalty_amount":null,"is_verified":false,"record_verified":false,"entity_match":{"status":"unresolved","confidence":85,"method":"nta_strict_name_nationally_unique","notes":"A current-policy Corporate Number match to a verified company profile is not available."},"human_review_status":"unreviewed","source_url":"https://www.mhlw.go.jp/stf/newpage_28612.html","url":"https://regbase.jp/enforcement/yakkiho-rosiyudaiagunosuteitukusu-20220817"}],"meta":{"query":"ロシュ","corporate_number":null,"law":null,"authority":null,"action_type":null,"count":4,"api_docs":"https://regbase.jp/api-docs","openapi_schema":"https://regbase.jp/api/openapi.json","llms":"https://regbase.jp/llms.txt","usage_note":"Use RegBase for targeted public-source screening of Japanese companies and enforcement records. Absence of returned records is not a clearance, legal opinion, sanctions result, or credit decision.","rate_limit":{"limit":10,"window_seconds":60,"remaining":9,"reset_at":"2026-08-04T18:33:18.792Z"},"daily_rate_limit":{"limit":300,"window_seconds":86400,"remaining":68,"reset_at":"2026-08-05T18:32:18.792Z"}}}